← Back to Clinical Research · Sponsor: Eli Lilly · Duration: ~14 months · up to 22 visits · ClinicalTrials.gov: NCT06297603
Currently Recruiting · Clinical Research
TRANSCEND-T2D-3 — Retatrutide in T2D with Renal Impairment
Investigating the efficacy and safety of Retatrutide — a novel triple incretin-hormone agonist — in adults with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin.
About This Study
What is being studied?
This study evaluates the efficacy and safety of Retatrutide at doses of 4 mg, 9 mg, or 12 mg administered once weekly for 52 weeks, compared with placebo, in participants with Type 2 Diabetes and renal impairment whose blood sugar is inadequately controlled on basal insulin alone or basal insulin combined with metformin and/or an SGLT2 inhibitor.
Retatrutide is a novel triple incretin-hormone agonist, acting at the gastric inhibitory polypeptide (GIP) receptor, the glucagon-like peptide-1 (GLP-1) receptor, and the glucagon receptor. Earlier-phase studies have shown high efficacy in the treatment of obesity, Type 2 Diabetes, and non-alcoholic fatty liver disease.
How does this fit with current medications?
| Medication | Receptor activity |
|---|---|
| Semaglutide (Ozempic) | Single agonist — GLP-1 |
| Tirzepatide (Mounjaro) | Dual agonist — GIP + GLP-1 |
| Retatrutide (investigational) | Triple agonist — GIP + GLP-1 + glucagon |
The renal-impairment population is particularly important because patients with reduced kidney function have historically had fewer treatment options and are at higher risk of complications from poor glycemic control. This study is designed to provide rigorous data in exactly that group.
Eligibility Criteria
Who can participate?
Eligibility is determined at a screening visit. Final inclusion is confirmed only after a full review of the protocol-mandated criteria.
Key Inclusion Criteria
- Age ≥ 18 years at the time of consent
- Diagnosis of Type 2 Diabetes
- HbA1c between 7.0% and 10.5%
- Moderate or severe renal impairment: eGFR 15 to < 60 mL/min/1.73m² (≥ 45 if on metformin)
- BMI ≥ 23.0 kg/m²
- On stable diabetes treatment for ≥ 90 days: basal insulin ≥ 20 IU/day, with or without metformin and/or SGLT2 inhibitor
Key Exclusion Criteria
- Type 1 Diabetes
- History of severe hypoglycemia or hypoglycemia unawareness within the last 6 months
- Receiving or planning treatment for diabetic retinopathy or diabetic macular edema
- Unstable or rapidly progressing renal disease
- Prior or planned bariatric surgery
- Congestive heart failure NYHA Class III or IV
- Acute MI, stroke, or hospitalization for heart failure within 90 days of screening
What Participation Involves
What can I expect?
This is a 14-month study with up to 22 visits. The pace is more intensive than some trials because of the careful monitoring required in patients with kidney disease, and because the protocol calls for detailed assessment of renal function, glycemic control, and safety throughout treatment.
If you appear to qualify based on initial conversation, the screening visit confirms eligibility. After informed consent, participants are randomized to receive Retatrutide at one of three doses or placebo, all in addition to their existing basal insulin regimen.
Generous visit stipends are provided. Study-related care and investigational product are at no cost to you. Participation is voluntary; withdrawal at any point is permitted and does not affect your ongoing clinical care.
Interested?
Talk to our research team
Renal-impairment trials require careful matching of patient and protocol. The most efficient way to find out whether TRANSCEND-T2D-3 fits your situation is a brief conversation with our research coordinator.
Phone: 619-463-1293
Email: info@endotrials.org